Month: August 2016

Too many women who have suffered transvaginal mesh complications wonder how it was ever approved by the FDA and why it took the agency so long to classify the mesh as a high-risk medical device. And when TVM victims find out, they are furious at both the FDA and the mesh makers.

A recent study published in Obstetrics and Gynecology (May 4, 2016) by Northwestern University researchers criticizes the FDA for approving a number of high-risk women’s health devices, including transvaginal mesh, based on weak clinical studies.

“Although it is impossible to know retrospectively whether more rigorous regulation would have prevented complications associated with [transvaginal mesh], it may have provided earlier warning of patient safety risks,” said lead researcher Dr. Steve Xu.

High-risk medical device

Transvaginal mesh was approved under a fast-track FDA process that deemed it similar to older mesh products. In fact, about 90 percent of medical devices sold in the United States are cleared under this 501(k) process, which is “a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval,” according to the FDA website. But the new mesh devices were not similar to the older types.

It took the FDA until the beginning of this year to classify the transvaginal mesh as a class III, or high-risk, medical device. Manufacturers will now be required to submit premarket approval applications demonstrating the safety and effectiveness of their products. Devices posing the highest potential risk to patients, such as pacemakers, must submit enough clinical data to the FDA that demonstrates safety and effectiveness. Transvaginal mesh was approved by the fast-track process and did not require so much clinical data. But it now falls into the same category as life-support or life-sustaining devices – e.g., pacemakers and heart valves.

From the FDA’s database, the Northwestern researchers studied 18 high-risk devices that were approved between 2000 and 2015. Of the 18, four devices did not demonstrate effectiveness, six were not required to conduct post-marketing safety studies, and three have been withdrawn from the market by makers because of safety or other problems.

Xu also voiced concern that the 21st Century Cures Act – legislation that has passed the House and is being considered in the Senate – would make device regulation even weaker. Critics of the Act say that it would speed up medical “innovation” by weakening the FDA and its standards for drug and medical device approval. And it would increase pharmaceutical companies’ profits. They will no doubt need increased profits to cover increased medical device lawsuits.

Harnessing a successful tactic used in Mirena IUD litigation two years ago, defendants in other Mass Tort cases are using a “mass production method” to dismiss plaintiff cases where the statute of limitations has run.

“One mass production method to knock out cases where the SOL has run is to set up a procedure for the defendant to challenge cases in groups, applying their facts to some precedents established in lead cases,” says Paul D. Rheingold, Of Counsel with Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP in New York.

Step one: In the Mirena IUD litigation, at the defense’s bequest the MDL judge established a mass statute of limitations evaluation procedure. First she adjudicated a “typical” case where the statute of limitations period in the state had run when suit was filed, as timed from the point when plaintiff learned that the IUD had embedded. She granted the defense motion in that case and dismissed it.

Step two: Then, as planned, defendant moved in waves of cases to dismiss, alleging the facts to be the same as the test case.

“It seems that Bayer attacked about 179 cases on the SOL in waves (out of several thousand filed). Of these, 46 opposed the motion, but all were unsuccessful. Almost all of the remainder were dismissed voluntarily or did not oppose the motion. Thus, it seems that Bayer had some modest success in repruning the volume,” Rheingold says

“In most MDLs, the defendant picks off cases one-by-one and seeks summary judgment on a SOL defense, generally in bellwether cases after there has been full discovery. That appears to me the best solution to the potential SOL defense,” he says.

As it turned out, the U.S. District Judge presiding over all federal Mirena IUD litigation granted summary judgment, dismissing at least 1,300 product liability lawsuits against Bayer, according to Aboutlawsuits.com.

Following several years of pretrial litigation, U.S. District Judge Cathy Seibel in the Southern District of New York issued an order (PDF) on July 28, granting a motion for summary judgment filed by Bayer. The decision came following a ruling in March, in which the judge excluded the testimony of several plaintiffs’ expert witnesses, leaving them without the ability to establish causation in their cases.

Tetralogy of fallot, which is a combination of several congenital heart defects.

Affirming a trial court ruling, an Illinois appeals court ruled that GlaxoSmithKline (GSK) will have to face a lawsuit in a Cook County, Illinois, court charging that its antidepressant drug Paxil causes birth defeats.

The First District Appellate Court denied an appeal by GSK, and upheld the ruling by Judge Larry G. Axelrood that the company’s “substantial-in-state contacts” gave state courts jurisdiction, including over complaints filed by out-of-state plaintiffs.

Catastrophic birth defects

The suit alleges that the minor plaintiffs suffered catastrophic birth defects as a result of their mothers’ ingestion of Paxil. Defendant GSK moved to dismiss the claims of the out-of-state plaintiffs, arguing that the court lacked both general and specific jurisdiction. However, the trial court found that Illinois had specific personal jurisdiction over defendant GSK based on:

GSK’s substantial in-state contacts, namely its contracts with 17 Illinois physicians to run 18 to 21 clinical trials on Paxil in Illinois as part of a multi-center study and,

The fact that plaintiffs’ claims arose from defendant GSK’s acts or omissions related to those trials.

The plaintiffs allege that there was a “significantly increased risk of congenital defects in babies whose mothers ingested” the drug. This knowledge was “scientifically knowable through appropriate research and testing.” Plaintiffs allege that the FDA requires defendant GSK “to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and [Paxil].” Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession.

The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

Inadequately cautioned patients

Despite defendant GSK’s opportunity and duty to strengthen the drug’s warnings, it “touted [Paxil] as being safe for pregnant women” and “aggressively *** promoted” the drug with labels that inadequately cautioned patients of the associated risk factors, thus, misrepresenting the drug to the public and to the medical profession. The complaint alleges that, had defendant GSK apprised plaintiffs’ physicians of Paxil’s risks, they would not have “prescribed or permitted” plaintiffs to use the drug. Likewise, had defendant GSK provided timely and “adequate warnings regarding the risks” of Paxil, plaintiffs would not have ingested the drug.

Meanwhile in the Philadelphia County Court of Common Pleas, Judge Arnold New denied GSK’s motions on July 12 to lift a stay on litigation over birth defects allegedly caused by the antidepressant Paxil, according to Law360. The court entered the stay on April 21 over the mass tort litigation until an appeal is decided in the initial case, Rader et al. v. SmithKlineBeecham Corp. et al.

Braden Rader was born with tetralogy of fallot, a combination of several congenital heart defects, allegedly caused by his mother’s use of Paxil during her 2003 pregnancy. GSK argued unsuccessfully that the stay should be lifted because the other Paxil cases have dispositive issues that are unconnected to the Rader decision, according to Law360. It also argued that the stay does not advance a timely resolution of the litigation.

A total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.

The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.

2 billion to resolve its civil liabilities with the federal government under the False Claims Act. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.

Two lead plaintiffs in the Taxotere (Docetaxel) Products Liability Litigation have filed a motion with the US Judicial Panel on Multidistrict Litigation to consolidate cases filed before 30 different federal judges into one MDL in the Eastern District of Louisiana.

“Movants anticipate that the number of Taxotere cases will grow exponentially and that thousands of Taxotere cases will be filed in the federal courts, particularly because, at the direction of the FDA, Defendants recently modified the prescribing information for Taxotere to indicate, for the first time in the U.S. label, that the drug may cause permanent hair loss,” the motion says.

Disfiguring hair loss for women

Product liability actions are proliferating in federal courts across the country, charging that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not.

“Defendants failed to update the warnings for Taxotere, failed to disclose the results of additional studies despite learning the facts with respect to the risks of Taxotere, fraudulently concealed the fact that Taxotere caused permanent alopecia unlike other taxanes used for the treatment of breast cancer, and engaged in a fraudulent marketing scheme, which involved paying kickbacks and providing other unlawful incentives to entice physicians to use Taxotere,” the motion says.

The lawsuit was filed by Juliette Boyd, a woman from Florida who was implanted with the Meridian® Vena Cava Filter in September 2012. She is represented by Ben C. Martin of the Law Offices of Ben C. Martin in Dallas, Texas.

She accuses C.R. Bard of negligence for selling a defective medical device, failing to warn about side effects, and concealing safety risks.

It took the FDA 10 years to issue a safety communication stating on May 6, 2014 that “the risk of having an IVC filter in place is expected to outweigh the benefits.” Later that year the FDA started a nine-month investigation and issued two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC-filters facilities.

The New Jersey Supreme Court ruled that 1,000 lawsuits filed against the generic makers of Reglan, a gastric reflux drug, can proceed in state court and that the claims are not pre-empted by federal law. The manufacturers failed to match the warnings in brand-name labeling that long-term use of the drug causes severe neurological disorders.

For the third time in two years, the New Jersey courts have denied defense arguments that claims brought under the New Jersey Product Liability law are pre-empted by federal law, and ruled that the holding in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) does not apply.

No pre-emption

“Federal preemption is inapplicable because defendants did not have to violate federal law in order to comply with state law, and it was not impossible to comply with both federal and state law,” the court said. “Plaintiffs’ state law claims highlight the inadequacy of the warnings for a drug, which if used for a prolonged period, could cause grave harm.”

“No law prevented defendants from giving the same warnings that appeared on the labeling of the brand-name drug — the warnings that plaintiffs contend the [New Jersey Product Liability Act] required,” the NJ Supreme Court said. “Defendants did not have to violate federal law to comply with state law.”

In 2004, the brand-name manufacturer of Reglan, known generically as metoclopramide, received approval from the FDA to publish new label warnings about the dangers of the long-term use of the drug. The plaintiffs took metoclopramide, the generic form of Reglan. The generic drug manufacturers did not timely upgrade their label warnings to match the FDA-approved brand-name labeling. Due to the allegedly inadequate generic drug warnings, the plaintiffs took metoclopramide beyond the prescribed period, causing them to develop tardive dyskinesia, a neurological disorder characterized by involuntary, repetitive body movements.

The plaintiffs filed failure-to-warn product-liability actions against defendants in New Jersey state court. The defendants argued that federal law preempts plaintiffs’ state-law claims. The trial court denied the defendants’ motion to dismiss and denied their motions for summary judgment. The Appellate Division upheld the ruling and now the Supreme Court affirmed as well.

Louis Bogard

“Defendants have managed to delay this litigation for years through endless rounds of interlocutory appeals,” Louis Bograd of Motley Rice LLC, who argued for the consumers, told Law360.

“Had defendants provided the same labeling as the brand-name manufacturers, as required by federal law, defendants would have enjoyed a safe harbor. Here, however, defendants did not provide the same warning labels that the FDA approved for the brand-name manufacturers. As alleged, defendants’ inadequate labeling breached a duty of care under the New Jersey Product Liability Act (PLA), N.J.S.A. 2A:58C-1 to -11,” the NJ Supreme Court ruled.

An appellate split

The ruling creates a split among appellate courts, according to Law360:

In a 2013 decision, a Fifth Circuit panel decided not to revive failure-to-warn claims against generic makers, finding that they didn’t have a duty to warn about the health risks of Reglan because brand-name manufacturers didn’t take action.

The California Court of Appeal, 2d District, upheld an $8.3 million verdict against DePuy Orthopaedics, Inc., and in favor of a grandfather whose life was ruined by a DePuy ASR XL metal-on-metal hip implant.

Plaintiff Loren Kransky died while the appeal was pending, after suffering poisonous cobalt and chromium debris from the defective implant. The jury found DePuy strictly liable under Montana law for the defective design of a hip implant that doctors ultimately had to remove in a risky and painful revision surgery. The jury awarded him more than $8.3 million:

$338,136.12 in economic damages for medical expenses and,

$8 million in noneconomic damages.

DePuy challenged several evidentiary rulings, including the exclusion of evidence related to the hip implant’s clearance by the FDA, and the admission of certain testimony by Kransky’s expert witness and his treating physician. DePuy also argued that the jury’s verdict was not supported by substantial evidence and is internally inconsistent.

In a forceful smackdown of defense arguments, the court ruled, “The trial court did not abuse its discretion in any of its evidentiary rulings. We conclude that the verdict is supported by substantial evidence and is not irreconcilable. We conclude that the $8.3 million compensatory damages award is not so grossly out of proportion as to shock the conscience.”

High rate of problems

Kransky was one of many patients who experienced problems with an ASR XL
implant. As early as 2006, surgeons began to observe an unusually high rate of problems with the ASR XL. These problems included “component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain.”

Data from national registries of hip implants around the world began reflecting higher than expected rates of revision surgery for the ASR XL. Australia, one of the first countries where DePuy sold the ASR XL, showed a five-year revision rate of 22 percent, as did English and Welsh registries. (DePuy’s other metal-on-metal hip implants on the market at the time averaged five-year revision rates of approximately 4 percent.) In 2010, when the failure rates of the ASR XL implant were widely known, DePuy voluntarily recalled the implant before the FDA took any action.

On the recall form DePuy filed with the FDA, DePuy checked a box to indicate that the recall was the result of a “defective product that would affect product performance and/or could cause health problems.”

In February 2012 an orthopedic surgeon successfully performed the revision surgery, removing the ASR XL. A biomedical engineer analyzed Kransky’s ASR XL implant and found evidence of “much more than normal” metal wear on the implant. The engineer also found black-stained tissue attached to the back of the implant’s cup. The engineer concluded that the ASR XL implant was defective because of excessive rim loading (the engineering term for when the head of the implant gets too close to the rim of the cup) that released a harmful amount of toxic metal debris.

Trial court rulings

At trial, the court exluded evidence that the FDA cleared the device for sale, because DePuy would mischaracterize the evidence and confuse the jury regarding the FDA’s approval, because the agency had cleared the implant under an abbreviated review process provided by section 510(k) of the Food, Drug, and Cosmetic Act, rather than under the FDA’s comprehensive Premarket Approval process, which is much more rigorous and focuses more specifically on the safety of the device.

The trial judge also denied defense motions to exclude opinion testimony by Kransky’s primary care physician, Thomas Trotsky, that chromium and cobalt debris from Kransky’s ASR XL implant was poisoning Kransky and that the implant was killing him. DePuy argued that Dr. Trotsky was not qualified to give such opinions because he was not a toxicologist. The court denied the motion, ruling that Dr. Trotsky had “sufficient qualifications to treat plaintiff and report the results of his treatment.”

Craig Swenson, an orthopedic surgeon with extensive experience with the ASR XL implant, testified as an expert witness for Kransky. He showed the jury pictures from five other revision surgeries that he had performed on other patients with the ASR XL implant. He used these pictures and information about these surgeries to explain to the jury how he believed the ASR XL failed and how it showed signs of such a failure.

DePuy objected to the admission of the pictures and to Dr. Swenson’s testimony about his other patients, arguing that it was improper expert testimony because his opinions were anecdotal and based on his “own personal experiences” rather than clinical studies, and that Kransky had not disclosed the pictures or any details about the other patients until a few days before trial. The court allowed Dr. Swenson to testify on direct examination, but delayed cross-examination to give DePuy an opportunity to take an additional, mid-trial session of Dr. Swenson’s deposition and to prepare for crossexamination on the five surgeries.

Damages not excessive

The trial court did not abuse its discretion in ruling that the $8 million verdict “does not shock the conscience” or “appear driven by passion or prejudice.” The jury heard evidence of Kransky’s severe pain, his loss of mobility, and his sincere and realistic fear of dying during the revision surgery.

Kransky testified that the defective hip gave him constant, debilitating, stabbing pain that prevented him from getting any rest. His “other illnesses would come and go,” but “[t]he hip [pain] was always there,” and there was “no way” to “get rid of any of the pain.”

For about five years Kransky could barely walk. He testified, “I would fall and I couldn’t trust myself to go out and mow the lawn.” He could no longer play with his grandchildren or attend their athletic events.

For nine months Kransky was confined to a wheelchair. At one point Kransky’s mobility problems prevented him from showering or going to the bathroom on his own. Kransky testified, “Well, my daughters are nurses, so they would help me [shower and go to the bathroom]. It’s very embarrassing to have your daughter have to help you do personal things like that. That went on for quite some time.”

The appeals court said, “The proper measure of compensatory damages must be determined solely based on the facts of each case, and juries have wide latitude in this regard. Because we find nothing in the jury’s verdict here to shock our conscience, the $8 million damages award is not excessive as a matter of law.”

Adam Warren of The Sentinel Group® in Temecula, CA, published an article saying it is crucial for attorneys to understand the ever-changing landscape of advertising and to keep a strong base of available TV time to generate lead/case acquisition flow.

“We have found tried and true strategies can fall short when developing mass media and local media plans for many mass tort campaigns and other single-event cases this year. Where we have overcome this challenge is having the ability to move quickly and precisely allowing us to pivot to alternative media strategies that are still efficient and cost-effective,” Warren says.

“Identifying fragmentation and TV programming changes per major events can be your next epic media win if you already have your pivot move in place. Make sure your marketing firm maintains a diverse breadth of experience and media portfolio and change will be your friend.”

Two lead plaintiffs in the Taxotere (Docetaxel) Products Liability Litigation have filed a motion with the US Judicial Panel on Multidistrict Litigation to consolidate cases filed before 30 different federal judges into one MDL in the Eastern District of Louisiana.

“Movants anticipate that the number of Taxotere cases will grow exponentially and that thousands of Taxotere cases will be filed in the federal courts, particularly because, at the direction of the FDA, Defendants recently modified the prescribing information for Taxotere to indicate, for the first time in the U.S. label, that the drug may cause permanent hair loss,” the motion says.

Disfiguring hair loss for women

Product liability actions are proliferating in federal courts across the country, charging that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not.

“Defendants failed to update the warnings for Taxotere, failed to disclose the results of additional studies despite learning the facts with respect to the risks of Taxotere, fraudulently concealed the fact that Taxotere caused permanent alopecia unlike other taxanes used for the treatment of breast cancer, and engaged in a fraudulent marketing scheme, which involved paying kickbacks and providing other unlawful incentives to entice physicians to use Taxotere,” the motion says.

The motion argues that the US District Court in New Orleans is the most appropriate because:

Five cases are currently pending in the Eastern District of Louisiana.

The Eastern District of Louisiana is home to many respected jurists who have expeditiously and successfully handled multidistrict and complex litigation.

The District has sufficient capacity to adjudicate this litigation, as many of the larger MDL cases within the District have been resolved or are drawing to a close.

New Orleans is an easily accessible and convenient forum for the anticipated number of geographically dispersed cases that are on file and expected to be filed.

The Clerk of Court has done a remarkable job in efficiently managing complex multidistrict litigations, many of which involved large numbers of daily filings.

Warnings overseas, but not in the US

Thousands of women of never got the chance to make an informed decision about their cancer treatment because the words “permanent alopecia” or “permanent hair loss” did not appear in any Taxotere information available in the U.S. — even though Sanofi had provided such information to doctors and patients in other countries.

As a direct result of defendants’ fraudulent marketing scheme, the defendants dramatically increased revenue on sales of Docetaxel from $424 million in 2000 to $1.4 billion in 2004.

A woman who used the antibiotic Levaquin and developed permanent nerve damage has filed a class action lawsuit accusing Janssen Pharmaceuticals of failing to adequately warn patients and doctors about the risk of severe nerve damage from Levaquin.

The lawsuit (PDF) was filed on August 11 by Michelin Rowell, a woman from North Carolina who was diagnosed with peripheral neuropathy. She is seeking class action status on behalf of everyone who was injured.

The case is Rowell v. Johnson & Johnson et al, Case No. 2:16-CV-04369 in the U.S. District Court for the Eastern District of Pennsylvania. The plaintiff argues that the running of any statute of limitations has been tolled by reason of Defendants’ fraudulent concealment of risks associated with
Levaquin.

State and federal litigation

Nearly 400 peripheral neuropathy lawsuits filed against the manufacturers of Levaquin, Cipro and Avelox continue are pending in Levaquin Litigation MDL 1943 in U.S. District Court in Minnesota.

Additional claims with similar allegations regarding the potential for fluoroquinolone antibiotics to cause peripheral neuropathy and permanent nerve damage have been filed in the Philadelphia Court of Common Pleas.

The defendants include Bayer (Cipro and Avelox), Janssen (Levaquin), and McKesson (a distributor).

Peripheral neuropathy was added to the label in 2004, but Janssen said nerve damage was a “rare” side effect that would go away when Levaquin was discontinued. The problem is that studies dating back to 2001 concluded that symptoms usually developed within a week, and in most cases problems persisted for at least one year.

In August 2013, the FDA ordered Janssen to update the label with stronger warnings about peripheral neuropathy. The word “rare” was removed and the new warnings emphasize the rapid onset of symptoms and potentially permanent complications, even if Levaquin is discontinued.

In May 2016, the FDA issued another warning about “disabling” side effects that “generally outweigh the benefits” when Levaquin is prescribed for common infections like sinusitis, bronchitis, and uncomplicated urinary tract infections (UTIs).